a4b7 Integrin in Eosinophilic Esophagitis

Inclusion criteria

• Able to give written informed consent
• Male or female patients aged 18-65 years at time of screening
• Confirmed active EoE at screening or within 8 weeks prior to baseline visit, as defined by esophageal mucosal eosinophils ≥15 per high power field (HPF, 400X magnification) despite at least 4 weeks of proton pump inhibitor (PPI) therapy with omeprazole 20 mg twice daily or the equivalent. updated 14APR2015 Page 8 of 19
• Within the week prior to dosing, patient has one of the following symptoms of moderate, or worse, severity: dysphagia, vomiting, regurgitation, abdominal pain, chest pain/heartburn.
• Maintained on a stabilized diet for at least 6 weeks prior to screening and during the course of the study; stable diet is defined as no initiation of single or multiple elimination diets or reintroduction of previously eliminated food groups.
• Willing and able to comply with all clinic visits and study-related procedures
• Able to understand and complete study-related questionnaires

Exclusion criteria

• Another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome, Churg-Strauss, parasitic infection)
• History of abnormal gastric or duodenal biopsy or documented GI disorders other than EoE (e.g., celiac disease, Crohn's disease or H. pylori infection)
• History of the following GI surgeries: fundoplication, gastric surgery or surgery for esophageal atresia
• Use of systemic immunosuppressive or immunomodulating agents (oral prednisone, anti-immunoglobulin E (IgE) monoclonal antibody (mAb), methotrexate, cyclosporine, INFα, or anti-TNF) within six months prior to study entry.
• A stricture on endoscopy that prevents passage of the endoscope
• Participation in any investigational drug or device study within 30 days prior to study entry.
• Female subjects who are pregnant or nursing.
• Chronic infections such as HIV, hepatitis B or C, active mycobacterial (TB) or fungal infections.
• Neoplasm or a history of malignancy in the preceding 5 years.
• Concurrent infection or disease that may preclude assessment of eosinophilic esophagitis.